Alka-seltzer Plus ®

SPL v10

SPL

SPL Set ID f4c60ca1-ba59-4a92-84a5-6ba65faa56ab

Route

ORAL

Published

Effective Date 2018-02-27

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (650 mg) Dextromethorphan (20 mg) Doxylamine (12.5 mg) Phenylephrine (10 mg)

Inactive Ingredients

Acesulfame Potassium Anhydrous Citric Acid D&c Yellow No. 10 Fd&c Red No. 40 Trisodium Citrate Dihydrate Sucralose Tartaric Acid Tribasic Calcium Phosphate Starch, Corn Sucrose Menthol Lemon Honey Silicon Dioxide

Identifiers & Packaging

Pill Appearance

Color: yellow

Marketing Status

OTC MONOGRAPH DRUG Completed Since 2014-04-17 Until 2020-04-30

Description

Drug Facts

Medication Information

Description

Drug Facts

Uses

temporarily relieves these symptoms due to a cold or flu:
- headache
- minor aches and pains
- cough
- sore throat
- nasal congestion
- sinus congestion and pressure
- runny nose
- sneezing
temporarily reduces fever

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Active ingredients (in each packet)	Purposes
Acetaminophen 650 mg	Pain reliever/fever reducer
Dextromethorphan hydrobromide 20 mg	Cough suppressant
Doxylamine succinate 12.5 mg	Antihistamine
Phenylephrine hydrochloride 10 mg	Nasal decongestant

Directions

do not take more than the recommended dose
take every 4 hours; do not exceed 5 packets in 24 hours or as directed by a doctor
adults and children 12 years and over: dissolve contents of one packet in 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes.
children under 12 years: do not use

Do Not Use

with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
if you have ever had an allergic reaction to this product or any of its ingredients
in children under 12 years of age

Liver Warning

This product contains acetaminophen. Severe liver damage may occur if you take

more than 5 packets in 24 hours, which is the maximum daily amount for this product
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product

Other Information

each packet contains: potassium 5 mg and sodium 5 mg
store at room temperature

Sore Throat Warning

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use to sedate children.

Inactive Ingredients

acesulfame potassium, anhydrous citric acid, compressible sugar, D&C yellow #10, dental-type silica, FD&C red #40, flavors, pregelatinized starch, sodium citrate, sucralose, tartaric acid, tribasic calcium phosphate

Questions Or Comments?

1-800-986-0369

(Mon-Fri 9AM - 5PM EST)

When Using This Product

do not exceed recommended dosage
may cause marked drowsiness
avoid alcoholic drinks
alcohol, sedatives, and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinery
excitability may occur, especially in children

Stop Use and Ask A Doctor If

pain, cough, or nasal congestion gets worse or lasts more than 7 days
fever gets worse or lasts more than 3 days
redness or swelling is present
new symptoms occur
cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
nervousness, dizziness, or sleeplessness occurs

Ask A Doctor Before Use If You Have

liver disease
heart disease
high blood pressure
thyroid disease
diabetes
glaucoma
cough with excessive phlegm (mucus)
a breathing problem such as emphysema or chronic bronchitis
difficulty in urination due to enlargement of the prostate gland
persistent or chronic cough such as occurs with smoking, asthma, or emphysema

Principal Display Panel 6 Packet Carton

Alka-Seltzer PLUS ^®

Severe

Cold & Flu

Honey Lemon Zest

Fast Relief Mix-In Packets

Night

Acetaminophen / Pain reliever-fever reducer

Doxylamine succinate / Antihistamine

Phenylephrine HCl / Nasal decongestant

Dextromethorphan HBr / Cough suppressant

• Nasal Congestion

• Headache

• Sore Throat

• Body Ache

• Cough

• Runny Nose

• Fever

6 PACKETS

Ask A Doctor Or Pharmacist Before Use If You Are

taking the blood thinning drug warfarin
taking sedatives or tranquilizers

Structured Label Content

Uses

temporarily relieves these symptoms due to a cold or flu:
- headache
- minor aches and pains
- cough
- sore throat
- nasal congestion
- sinus congestion and pressure
- runny nose
- sneezing
temporarily reduces fever

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Active ingredients (in each packet)	Purposes
Acetaminophen 650 mg	Pain reliever/fever reducer
Dextromethorphan hydrobromide 20 mg	Cough suppressant
Doxylamine succinate 12.5 mg	Antihistamine
Phenylephrine hydrochloride 10 mg	Nasal decongestant

Directions

do not take more than the recommended dose
take every 4 hours; do not exceed 5 packets in 24 hours or as directed by a doctor
adults and children 12 years and over: dissolve contents of one packet in 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes.
children under 12 years: do not use

Do Not Use (Do not use)

with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
if you have ever had an allergic reaction to this product or any of its ingredients
in children under 12 years of age

Liver Warning (Liver warning)

This product contains acetaminophen. Severe liver damage may occur if you take

more than 5 packets in 24 hours, which is the maximum daily amount for this product
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product

Other Information (Other information)

each packet contains: potassium 5 mg and sodium 5 mg
store at room temperature

Sore Throat Warning (Sore throat warning)

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use to sedate children.

Inactive Ingredients (Inactive ingredients)

Questions Or Comments? (Questions or comments?)

1-800-986-0369

(Mon-Fri 9AM - 5PM EST)

When Using This Product (When using this product)

do not exceed recommended dosage
may cause marked drowsiness
avoid alcoholic drinks
alcohol, sedatives, and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinery
excitability may occur, especially in children

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

pain, cough, or nasal congestion gets worse or lasts more than 7 days
fever gets worse or lasts more than 3 days
redness or swelling is present
new symptoms occur
cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
nervousness, dizziness, or sleeplessness occurs

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

liver disease
heart disease
high blood pressure
thyroid disease
diabetes
glaucoma
cough with excessive phlegm (mucus)
a breathing problem such as emphysema or chronic bronchitis
difficulty in urination due to enlargement of the prostate gland
persistent or chronic cough such as occurs with smoking, asthma, or emphysema

Principal Display Panel 6 Packet Carton (PRINCIPAL DISPLAY PANEL - 6 Packet Carton)

Alka-Seltzer PLUS ^®

Severe

Cold & Flu

Honey Lemon Zest

Fast Relief Mix-In Packets

Night

Acetaminophen / Pain reliever-fever reducer

Doxylamine succinate / Antihistamine

Phenylephrine HCl / Nasal decongestant

Dextromethorphan HBr / Cough suppressant

• Nasal Congestion

• Headache

• Sore Throat

• Body Ache

• Cough

• Runny Nose

• Fever

6 PACKETS

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking the blood thinning drug warfarin
taking sedatives or tranquilizers

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves these symptoms due to a cold or flu: headache minor aches and pains cough sore throat nasal congestion sinus congestion and pressure runny nose sneezing temporarily reduces fever", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "Active ingredients (in each packet) Purposes Acetaminophen 650 mg Pain reliever/fever reducer Dextromethorphan hydrobromide 20 mg Cough suppressant Doxylamine succinate 12.5 mg Antihistamine Phenylephrine hydrochloride 10 mg Nasal decongestant", "Directions": "do not take more than the recommended dose take every 4 hours; do not exceed 5 packets in 24 hours or as directed by a doctor adults and children 12 years and over: dissolve contents of one packet in 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes. children under 12 years: do not use", "Do not use": "with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. if you have ever had an allergic reaction to this product or any of its ingredients in children under 12 years of age", "Liver warning": "This product contains acetaminophen. Severe liver damage may occur if you take more than 5 packets in 24 hours, which is the maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product", "Other information": "each packet contains: potassium 5 mg and sodium 5 mg store at room temperature", "Sore throat warning": "If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. Do not use to sedate children.", "Inactive ingredients": "acesulfame potassium, anhydrous citric acid, compressible sugar, D&C yellow #10, dental-type silica, FD&C red #40, flavors, pregelatinized starch, sodium citrate, sucralose, tartaric acid, tribasic calcium phosphate", "Questions or comments?": "1-800-986-0369 (Mon-Fri 9AM - 5PM EST)", "When using this product": "do not exceed recommended dosage may cause marked drowsiness avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children", "Stop use and ask a doctor if": "pain, cough, or nasal congestion gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition. nervousness, dizziness, or sleeplessness occurs", "Ask a doctor before use if you have": "liver disease heart disease high blood pressure thyroid disease diabetes glaucoma cough with excessive phlegm (mucus) a breathing problem such as emphysema or chronic bronchitis difficulty in urination due to enlargement of the prostate gland persistent or chronic cough such as occurs with smoking, asthma, or emphysema", "PRINCIPAL DISPLAY PANEL - 6 Packet Carton": "Alka-Seltzer PLUS ® Severe Cold & Flu Honey Lemon Zest Fast Relief Mix-In Packets Night Acetaminophen / Pain reliever-fever reducer Doxylamine succinate / Antihistamine Phenylephrine HCl / Nasal decongestant Dextromethorphan HBr / Cough suppressant • Nasal Congestion • Headache • Sore Throat • Body Ache • Cough • Runny Nose • Fever 6 PACKETS", "Ask a doctor or pharmacist before use if you are": "taking the blood thinning drug warfarin taking sedatives or tranquilizers"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:10.020408 · Updated: 2026-03-14T23:12:19.459812